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STELARA CD PMS: Post-Marketing Surveillance for Crohn's Disease Participants Treated With Stelara (Ustekinumab)

Sponsor
Janssen Korea, Ltd., Korea (Industry)
Overall Status
Completed
CT.gov ID
NCT03942120
Collaborator
(none)
495
Enrollment
43
Locations
33.2
Actual Duration (Months)
11.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of post-marketing surveillance (PMS) is to assess the safety and effectiveness of ustekinumab (Stelara) for Crohn's disease participants under real world clinical practice.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
495 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Post-Marketing Surveillance for Crohn's Disease Patients Treated With STELARA
Actual Study Start Date :
Apr 8, 2019
Actual Primary Completion Date :
Jan 14, 2022
Actual Study Completion Date :
Jan 14, 2022

Arms and Interventions

Arm Intervention/Treatment
Participants with Crohn's Disease

Participants that are diagnosed with Crohn's disease will be observed in this study who are being treated with ustekinumab under real world clinical practice. Only data available per clinical practice will be collected within this study.

Drug: Ustekinumab
Participants treated with ustekinumab under real world clinical practice will be observed in this study. No study drug will be administered as a part of this study.
Other Names:
  • Stelara

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Adverse Events [Approximately up to 3 years]

      An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

    2. Change from Baseline in Crohn's Disease Activity Index (CDAI) Score [Baseline up to 3 years]

      CDAI is a scoring system to assess the symptoms of participants with Crohn's disease (CD). It consists of 8 different CD-related factors that are summed after adjustment with a weighting factor. These 8 variables are: extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid stools, abdominal pain/cramping, and general well-being. CDAI total score ranges from 0 to 900 and a decrease over time indicates improvement in disease activity.

    3. Change from Baseline in C-reactive Protein (CRP) Concentration [Baseline up to 3 years]

      Change from baseline in CRP concentration will be assessed.

    4. Change from Baseline in Harvey-Bradshaw Index (HBI) Score [Baseline up to 3 years]

      HBI is a shorter and simpler alternative version of CDAI which consists of five parameters that allow physicians to quickly categorize the severity of Crohn's disease and detect remission. The 5 parameters are: general well-being (0-4, where higher score means lower well-being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day (score 1 per movement), abdominal mass (0=none, 1=dubious, 2=definite, 3=definite and tender), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools per day and number of complications, where higher scores indicate more severe disease and, score is presented as: less than (<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (>)16 (severe disease).

    5. Change from Baseline in Fecal Calprotectin Level [Baseline up to 3 years]

      Change from baseline in fecal calprotectin levels will be assessed. Elevated calprotectin level in the stool indicates that inflammation is present in the intestine and the degree of elevation is associated with the severity of the inflammation.

    6. Change from Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) [Baseline up to 3 years]

      SES-CD is a simplified endoscopic scoring system to evaluate Crohn's disease activity developed as an alternative to Crohn's disease endoscopic index of severity (CDEIS). It assesses the size of mucosal ulcers, the ulcerated surface, the endoscopic extension and the presence stenosis. Each endoscopic component is scored from 0 to 3 for each segment, and a total score is derived from the sum of all the component scores (range, 0 [remission] to 60 [the most severe endoscopic activity]).

    7. Change from Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score [Baseline up to 3 years]

      SIBDQ is a simple, validated 10-item self-reported questionnaire for participants with inflammatory bowel disease to evaluate participant-reported outcomes in 4 domains- digestive symptoms (3 items), systemic symptoms (2 items), emotional disturbance (3 items), and social function (2 items). Participants rate each item on a 7-point Likert scale (1=all of the time; 2=most of the time; 3=a good bit of the time; 4=some of the time; 5=a little bit of the time; 6=hardly any of the time; 7=none of the time). Total score is calculated by adding the scores from each domain; the total score ranges from 10 to 70, where minimum score =10 (poor quality of life) and maximum score =70 (good quality of life).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participants who are administered with Stelara for the first time for the indication of Crohn's disease in accordance with the label

    • Participants must sign a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements

    Exclusion Criteria:
    • Have contraindication to Stelara in accordance to the label

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Korea University Ansan Hospital Ansan-si Korea, Republic of 15355
    2 Inje University Busan Paik Hospital Busan Korea, Republic of 47392
    3 Inje University Haeundae Paik Hospital Busan Korea, Republic of 48108
    4 Kosin University Gospel Hospital Busan Korea, Republic of 48108
    5 Good Gangan Hospital Busan Korea, Republic of 48265
    6 Pusan National University Hospital Busan Korea, Republic of 49241
    7 Dong-A University Hospital Busan Korea, Republic of 602-812
    8 Changwon Kyunngsang University Hospital Changwonsi Korea, Republic of 51472
    9 Samsung ChangWon Hospital ChangWon Korea, Republic of 51353
    10 Dankook University Hospital Cheonan-si Korea, Republic of 31116
    11 Soonchunhyang University Cheonan Hospital Cheonan Korea, Republic of
    12 Hallym University Chuncehon Medical Center ChunCheon Korea, Republic of 24253
    13 Kangwon National University Hospital Chuncheon Korea, Republic of 24289
    14 Daegu Fatima Hospital Daegu Korea, Republic of 41199
    15 Kyongpook national university Medical center Daegu Korea, Republic of 41404
    16 Kyungpook National University Chilgok Hospital Daegu Korea, Republic of 41404
    17 Kyungpook National University Hospital Daegu Korea, Republic of 41944
    18 Yeungnam University Medical Center Daegu Korea, Republic of 42415
    19 Koo Hospital Daegu Korea, Republic of 42644
    20 Keimyung University Dongsan Hospital Daegu Korea, Republic of 700-712
    21 Konyang University Hospital Daejeon Korea, Republic of 302-718
    22 Chungnam National University Hospital Daejeon Korea, Republic of 35015
    23 Chunnam National University Hospital Gwangju Korea, Republic of 501-757
    24 Hallym University Dongtan Sacred Heart Hospital Hwaseong-si Korea, Republic of 18450
    25 GyeongSang National University Hospital Jinju Korea, Republic of 52727
    26 Bucheon Soonchunhyang Hospital Kyunggido Korea, Republic of
    27 The Catholic Univ. of Korea, DaeJeon St. Mary's Hospital Seongnam Korea, Republic of 13620
    28 CHA Bundang Medical Center, CHA University Seongnam Korea, Republic of 412-723
    29 Seoul National University Bundang Hospital Seongnam Korea, Republic of 463-707
    30 Pusan National University Yangsan Hospital Seoul Korea, Republic of 02447
    31 Seoul National University Hospital Seoul Korea, Republic of 03080
    32 Kangbuk Samsung Hospital Seoul Korea, Republic of 03181
    33 Soonchunhyang University Seoul Hospital Seoul Korea, Republic of 04401
    34 Asan Medical Center Seoul Korea, Republic of 05505
    35 Hallym University Medical Center Seoul Korea, Republic of 06351
    36 Samsung Medical Center Seoul Korea, Republic of 06351
    37 The Catholic University of Korea, Seoul St. Mary's Hospital Seoul Korea, Republic of 06591
    38 Chung-Ang University Hospital Seoul Korea, Republic of 06973
    39 KyungHee University Hospital Seoul Korea, Republic of 102-1703
    40 Yonsei University Severance Hospital - Dept.of Internal Medicine Seoul Korea, Republic of 120752
    41 Gangnam Severance Hospital Seoul Korea, Republic of 135-720
    42 Ewha Woman's University Hospital Seoul Korea, Republic of 158-710
    43 Pusan National University Yangsan Hospital Yangsan Korea, Republic of 50612

    Sponsors and Collaborators

    • Janssen Korea, Ltd., Korea

    Investigators

    • Study Director: Janssen Korea, Ltd., Korea Clinical Trial, Janssen Korea, Ltd., Korea

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Korea, Ltd., Korea
    ClinicalTrials.gov Identifier:
    NCT03942120
    Other Study ID Numbers:
    • CR108610
    • CNTO1275CRD4029
    First Posted:
    May 8, 2019
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Crohn Disease
    Ustekinumab

    Study Results

    No Results Posted as of Mar 31, 2022